Effect Of Zoledronic Acid On Circulating And Bone Marrow-Residing Prostate Cancer Cells In Patients With Clinically Localized Prostate Cancer

Phase 4CompletedNCT00219271

Novartis Pharmaceuticals60 enrolled

Overview

The objective of this study is to assess the effect Of zoledronic acid on circulating and bone marrow-residing prostate cancer cells in patients with clinically localized prostate cancer

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Zoledronic acidDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria * Prostate cancer * Radical prostatectomy or external beam irradiation therapy within 6 months before study entry. * No bone metastases according to bone scan Exclusion Criteria * Metastatic prostate cancer * Hormone ablation therapy for more than 3 months before/after radical prostatectomy and external beam irradiation therapy * Treatment with bisphosphonates or other drugs known to affect the skeleton within the past year. Other protocol-defined inclusion / exclusion criteria may apply.

Locations (1)

Novartis Investigative Site

Athens, Greece

Outcomes

Primary Outcomes

To assess the activity of one year treatment with zoledronic acid

Time frame: 12 mos

Secondary Outcomes

Three-year disease free survival

Time frame: 3 years

Change in bone mineral density at 12, 24 and 36 months versus baseline

Time frame: 12, 24 and 36 months

Changes in bone resorption markers at 12, 24 and 36 months versus baseline

Time frame: 12, 24 and 36 months

Safety and tolerability through abnormal values and AE reporting

Time frame: upto 36 mos

Data from ClinicalTrials.gov

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